Biopharmaceutical company HUYABIO International announced on Thursday that oral HBI-8000 in combination with intravenous nivolumab reduced the risk of disease progression or death by 27% compared with nivolumab alone in a global Phase 3 trial involving patients with advanced melanoma.

The combination demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), with median PFS of 11.7 months compared with 7.4 months for patients receiving nivolumab plus placebo. Together with its encouraging safety profile, the findings demonstrate the potential of HBI-8000 plus nivolumab to become an important new frontline treatment option for patients with advanced melanoma, HUYABIO said.

Data from the Phase 3 trial were presented at the European Society for Medical Oncology (ESMO) Congress 2026.

HBI-8000 is a highly differentiated selective Class I histone deacetylase (HDAC) inhibitor, designed to boost the immune response against cancer cells through epigenetic modification. By modifying the tumour microenvironment from non-responsive (cold) to responsive (hot), HBI-8000 has the potential to enhance the activity of anti-PD-1 checkpoint inhibitors such as nivolumab.

HUYABIO said that PFS results favoured HBI-8000 plus nivolumab across most prespecified subgroups. Overall survival (OS) data remain immature, with follow-up ongoing.